A long term clinical study to determine safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)
- Conditions
- Health Condition 1: null- Idiopathic Pulmonary Fibrosis
- Registration Number
- CTRI/2013/01/003290
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Signed Informed Consent consistent with ICH-GCP and local laws prior to trial
participation
Patients from trials 1199.32 or 1199.34 who completed the 52 weeks treatment period
and performed the follow-up visit
AST ALT more than 1.5 fold ULN
Patients who completed the parent trial with transaminase values more than 1.5 fold ULN but less than 3 fold ULN are considered eligible
Bilirubin more than 1.5 fold ULN
Bleeding risk
Patients who require fibrinolysis full dose therapeutic anticoagulation eg
vitamin K antagonists dabigatran heparin hirudin or high dose antiplatelet
therapy Exceptions prophylactic low dose heparin or heparin flush as needed
for maintenance of an indwelling intravenous device eg enoxaparin 4000 IU
sc per day) and prophylactic use of antiplatelet therapy eg acetyl salicylic
acid up to 325 mg per dayor clopidogrel at 75 mg per day or equivalent doses of other
antiplatelet therapy
Hemorrhagic CNS event gross frank haemoptysis or haematuria active
gastrointestinal bleeding or ulcers after completion of the parent trial
Coagulation parameters International normalised ratio INR more than 2 prothrombin
time PT and partial thromboplastin time PTT more than 150percent of institutional ULN
Planned major surgery within the next 3 months including lung transplantation major
abdominal or major intestinal surgery
New major thromboembolic events developed after completion of the parent trial
Stroke
Deep vein thrombosis
Pulmonary embolism
Myocardial infarction
Time period more than 12 weeks between Visit 9 of the parent trial and Visit 2 of this study
Usage of any investigational drug after completion of the parent trial or planned usage
of a specific investigational drug during the course of this trial
A disease or condition which in the opinion of investigator may put the patient at risk
because of participation in this trial or limit the patients ability to participate in this
trial
Alcohol or drug abuse which in the opinion of the investigator would interfere with
trial participation
Pregnant women or women who are breast feeding or of child bearing potential not
using two effective methods of birth control one barrier and one highly effective nonbarrier
for at least 1 month prior to Visit 2 and or not committing to using it until 3
months after end of treatment
Women will be considered to be of childbearing potential unless surgically sterilised
by hysterectomy or bilateral tubal ligation or postmenopausal for at least two years
Highly effective methods of birth control include established use of oral injected or
implanted hormonal methods of contraception placement of an intrauterine device
IUD or intrauterine system IUS A barrier method of contraception includes
condom or occlusive cap with spermicidal foam gel film cream suppository or
male sterilization with appropriate postvasectomy documentation of the absence of
sperm in the ejaculate
Sexually active men not committing to using condoms during participation in the
study except if their partner is not of childbearing potential and 3 months after the
last intake of BIBF 1120
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method